MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 2 LT 6MM; PROSTHESIS, ANKLE, CEMENTED, METAL/POLYMER

Model Number	TIBIAL INSERT FB SZ 2 LT 6MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department, a 68 y/o male patient recieved a left ankle replacement on (b)(6) 2021.Approximately 1 years and 3 months post initial the patient had a left ankle revision due to pain on (b)(6) 2023.The implants were carefully inspected and they were stable and well fixed to the surrounding bone.Trial polyethylene inserts were utilized to confirm that the size 2, 8 mm polyethylene insert provided the best fit and stability to the ankle without compromising motion.The size 8 mm insert was then inserted into the tibial component and locked in place utilizing a new tibial clip.The wounds were closed with nylon suture.The patient tolerated the procedure well with no complications.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Additional information- d7a, h6 medical device problem code.H3.Investigation results- the tibial insert fb sz 2 lt 6mm with sn (b)(6), is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and polyethylene exchange cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, left hindfoot valgus misalignment, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.No other information is available.

• Brand Name: TIBIAL INSERT FB SZ 2 LT 6MM
• Common Device Name: PROSTHESIS, ANKLE, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16763462
• Report Number: 1038671-2023-00729
• Device Sequence Number: 14183144
• Product Code: HSN
• UDI-Device Identifier: 10885862276223
• UDI-Public: 10885862276223
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: TIBIAL INSERT FB SZ 2 LT 6MM
• Device Catalogue Number: 350-21-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0024-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male